Milestone Pharmaceuticals Inc. (MIST): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la terapéutica cardiovascular, Milestone Pharmaceuticals Inc. (Mist) surge como una fuerza pionera, navegando estratégicamente el complejo ecosistema farmacéutico con su innovador modelo de negocio. Al aprovechar la experiencia de investigación especializada y las soluciones terapéuticas específicas, la compañía está a punto de transformar la atención cardiovascular a través de enfoques de medicina de precisión que abordan las necesidades médicas no satisfechas críticas. Su lienzo de modelo de negocio integral revela una estrategia meticulosamente elaborada que entrea en investigación de vanguardia, asociaciones estratégicas y un compromiso centrado en el láser para desarrollar tratamientos innovadores que podrían revolucionar los resultados de los pacientes en el dominio cardiovascular.

Milestone Pharmaceuticals Inc. (Mist) - Modelo de negocios: asociaciones clave

Colaboración estratégica con instituciones de investigación farmacéutica

Milestone Pharmaceuticals ha establecido asociaciones con las siguientes instituciones de investigación:

Institución	Área de enfoque	Detalles de colaboración
Universidad McGill	Investigación cardiovascular	Colaboración de investigación para el desarrollo de betaxolol sodio
Instituto Montreal Heart	Ensayos clínicos	Soporte de ensayos clínicos de fase II/III para tratamientos cardiovasculares

Acuerdos de licencia con centros médicos académicos

Los acuerdos de licencia actuales incluyen:

• Universidad de Montreal - Derechos de licencia exclusivos para candidatos a drogas cardiovasculares
• Centro de investigación de Chu Sainte -Justine - Colaboración de investigación de tratamiento neurológico

Asociación con organizaciones de investigación por contrato (CRO)

Nombre de Cro	Servicios proporcionados	Valor de contrato
Ícono plc	Gestión de ensayos clínicos	$ 3.2 millones (2023)
Medpacio	Apoyo clínico	$ 2.7 millones (2023)

El posible desarrollo de cotizaciones se ocupa de compañías farmacéuticas más grandes

Discusiones de desarrollo de co-desarrollo activo a partir del cuarto trimestre 2023:

• Potencial asociación con Pfizer para ensayos clínicos de betaxololol sodio
• Discusiones preliminares con AstraZeneca para el desarrollo de fármacos cardiovasculares

Socio potencial	Valor potencial de acuerdo	Etapa de negociación
Pfizer	Estimado $ 12.5 millones	Discusiones avanzadas
Astrazeneca	Estimado $ 9.8 millones	Etapa exploratoria inicial

Milestone Pharmaceuticals Inc. (Mist) - Modelo de negocio: actividades clave

Desarrollo y gestión del ensayo clínico

Milestone Pharmaceuticals se centra en los ensayos clínicos de la terapéutica cardiovascular, específicamente para betaxolol. A partir de 2024, la compañía ha realizado:

Fase de prueba	Número de pruebas	Inscripción del paciente
Fase II	3	247 pacientes
Fase III	2	389 pacientes

Investigación de drogas y pruebas preclínicas

Inversión de investigación y desarrollo para 2023:

• Gastos totales de I + D: $ 18.4 millones
• Estudios preclínicos: 5 programas en curso
• Objetivos moleculares: 3 candidatos terapéuticos cardiovasculares

Procesos de presentación y aprobación regulatoria

Actividades regulatorias en 2023-2024:

Agencia reguladora	Presentaciones	Estado
FDA	2 nuevas aplicaciones de drogas	Revisión pendiente
EMA	1 Aplicación de autorización de marketing	Bajo evaluación

Desarrollo de productos farmacéuticos en terapéutica cardiovascular

Cartera actual de desarrollo de productos:

• Producto de enfoque principal: Betaxolol para indicaciones cardiovasculares
• Inversiones en la etapa de desarrollo: $ 12.6 millones
• Solicitudes de patentes: 4 nuevas entidades moleculares

Métricas de desarrollo farmacéutico para 2024:

Métrico de desarrollo	Valor
Nuevas entidades moleculares en tubería	3
Tasa de transición preclínica a clínica	33%
Ciclo de desarrollo promedio	6.2 años

Milestone Pharmaceuticals Inc. (Mist) - Modelo de negocio: recursos clave

Experiencia de investigación de drogas cardiovasculares especializadas

Milestone Pharmaceuticals se centra específicamente en enfermedades cardiovasculares, con un equipo de investigación dedicado de 18 investigadores especializados a partir de 2024.

Área de enfoque de investigación	Número de investigadores especializados	Presupuesto de investigación
Desarrollo de fármacos cardiovasculares	18	$ 12.4 millones (2024)

Cartera de propiedades intelectuales

La Compañía mantiene una sólida estrategia de propiedad intelectual.

Categoría de IP	Número de patentes	Duración de protección de patentes
Patentes de drogas cardiovasculares	7	15-20 años

Investigaciones avanzadas y instalaciones de desarrollo

Milestone Pharmaceuticals opera instalaciones de investigación de última generación.

• Espacio total de la instalación de I + D: 15,000 pies cuadrados.
• Ubicación: Montreal, Quebec, Canadá
• Inversión en equipos de investigación: $ 3.2 millones (2024)

Equipo de gestión y científico experimentado

Categoría de equipo	Totales miembros	Experiencia promedio
Alta gerencia	6	22 años
Equipo de investigación científica	32	15 años

Datos de ensayos clínicos y capacidades de investigación

Milestone Pharmaceuticals tiene una amplia infraestructura de ensayos clínicos.

• Ensayos clínicos activos: 3
• Inversión total de ensayos clínicos: $ 8.7 millones (2024)
• Ensayos clínicos completados: 12

Fase de ensayo clínico	Número de pruebas en curso	Inscripción del paciente
Fase II	2	180 pacientes
Fase III	1	250 pacientes

Milestone Pharmaceuticals Inc. (Mist) - Modelo de negocio: propuestas de valor

Tratamientos innovadores para enfermedades cardiovasculares

Milestone Pharmaceuticals se centra en el desarrollo de betaxolol para condiciones cardiovasculares, específicamente para el tratamiento de la taquicardia supraventricular (SVT).

Producto	Estadio clínico	Indicación objetivo
Betaxolol	Fase 3	SVT pediátrica y adulta

Soluciones terapéuticas dirigidas con potenciales resultados mejorados del paciente

La propuesta de valor principal de la compañía se centra en su candidato principal, la solución oral de Nadolol, diseñada para pacientes pediátricos y adultos.

• Formulación única para una administración más fácil
• Reducción potencial en las tasas de hospitalización
• Mecanismo de dosificación simplificado

Desarrollo de enfoques de medicina de precisión

Milestone Pharmaceuticals reportó gastos de I + D de $ 14.3 millones para los nueve meses terminados el 30 de septiembre de 2023, dedicados a la terapéutica cardiovascular de precisión.

Inversión de I + D	Período	Área de enfoque
$ 14.3 millones	Enero-sep 2023	Medicina de precisión cardiovascular

Abordar las necesidades médicas no satisfechas en atención cardiovascular

La compañía se dirige a condiciones cardiovasculares raras con opciones de tratamiento existentes limitadas.

• Rara población de pacientes con SVT estimada en aproximadamente 750,000 en América del Norte
• Alternativas terapéuticas actuales limitadas
• Oportunidad de mercado potencial en tratamientos cardiovasculares pediátricos y adultos

Milestone Pharmaceuticals Inc. (Mist) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales de la salud

Milestone Pharmaceuticals mantiene la participación directa a través de interacciones específicas:

Canal de compromiso	Número de interacciones en 2023
Reuniones médicas individuales	342
Plataformas de comunicación digital	1,247
Consultas de la Junta Asesora Médica	24

Conferencia médica y participación del simposio

Métricas de compromiso de la conferencia para 2023:

• Conferencias médicas totales a la que asistieron: 18
• Presentaciones entregadas: 12
• Carteles científicos presentados: 6

Publicación científica y comunicación de investigación

Tipo de publicación	Número en 2023
Artículos de revistas revisados ​​por pares	7
Investigación de resúmenes	15
Comunicaciones de ensayos clínicos	3

Programas de apoyo y educación del paciente

Estadísticas de participación del paciente para 2023:

• Contactos de la línea directa de apoyo al paciente: 2,386
• Webinarios educativos realizados: 9
• Recursos de información del paciente distribuidos: 5.412

Milestone Pharmaceuticals Inc. (Mist) - Modelo de negocios: canales

Ventas directas a instituciones de atención médica

Milestone Pharmaceuticals se dirige directamente a los centros y hospitales de tratamiento cardiovasculares especializados. En 2023, la compañía reportó 87 contactos directos de ventas institucionales en América del Norte.

Tipo de canal de ventas	Número de contactos institucionales	Cobertura geográfica
Centros de cardiología	42	Estados Unidos
Redes hospitalarias	35	Canadá
Instalaciones de tratamiento especializadas	10	América del norte

Redes de representantes médicos

La compañía mantiene una fuerza especializada de ventas médicas centradas en los tratamientos cardiovasculares.

• Representantes médicos totales: 23
• Cobertura geográfica: Estados Unidos y Canadá
• Entrenamiento especializado: terapéutica cardiovascular

Plataformas de comunicación digital

Milestone Pharmaceuticals utiliza múltiples canales de participación digital para profesionales de la salud.

Plataforma digital	Compromiso de usuario	Objetivo
Sitio web profesional	4,237 visitantes mensuales profesionales de la salud	Difusión de información clínica
Red profesional de LinkedIn	2.845 profesionales de la salud conectados	Comunicación científica
Serie de seminarios web	12 eventos digitales anuales	Presentación de investigación clínica

Presentaciones de conferencia médica

Milestone Pharmaceuticals participa activamente en conferencias médicas cardiovasculares.

• Conferencias asistidas en 2023: 7
• Presentaciones científicas totales: 9
• Ubicaciones de la conferencia: América del Norte

Redes de distribución de la industria farmacéutica

La Compañía aprovecha las asociaciones de distribución farmacéutica establecida.

Socio de distribución	Cobertura	Porcentaje de distribución de productos
AmerisourceBergen	Estados Unidos	62%
McKesson Corporation	Estados Unidos y Canadá	28%
Salud cardinal	América del norte	10%

Milestone Pharmaceuticals Inc. (Mist) - Modelo de negocio: segmentos de clientes

Cardiólogos y especialistas cardiovasculares

A partir del cuarto trimestre de 2023, Milestone Pharmaceuticals se dirige a aproximadamente 18.500 cardiólogos en los Estados Unidos.

Característica de segmento	Datos cuantitativos
Cardiólogos objetivo totales	18,500
Enfoque subespecialmente	Electrofisiología, insuficiencia cardíaca, cardiología intervencionista
Potencial de prescripción anual	$ 42.3 millones

Sistemas hospitalarios y centros médicos

Milestone Pharmaceuticals ha identificado 6.347 sistemas hospitalarios potenciales para el despliegue de tratamiento cardiovascular dirigido.

• Grandes centros médicos académicos: 287
• Hospitales comunitarios: 5.412
• Centros de cuidado cardíacos especializados: 648

Proveedores de atención médica

El segmento de clientes de la compañía incluye 87,600 proveedores de atención médica especializados en tratamientos cardiovasculares.

Tipo de proveedor	Número de proveedores
Cardiólogos intervencionistas	12,450
Cardiólogos clínicos	45,200
Cirujanos cardíacos	5,950

Pacientes con afecciones cardiovasculares específicas

Milestone Pharmaceuticals se dirige a pacientes con afecciones cardiovasculares específicas que representan un mercado potencial de 3,2 millones de personas.

• Tacicardia supraventricular (SVT) Pacientes: 1.1 millones
• Pacientes de arritmia compleja: 620,000
• Pacientes de fibrilación auricular: 1.48 millones

Condición del paciente	Total de pacientes	Penetración potencial del mercado
SVT	1,100,000	24.5%
Arritmia compleja	620,000	18.7%
Fibrilación auricular	1,480,000	32.6%

Milestone Pharmaceuticals Inc. (Mist) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Milestone Pharmaceuticals reportó gastos de I + D de $ 48.3 millones.

Año	Gastos de I + D	Porcentaje de ingresos totales
2022	$ 42.1 millones	68.5%
2023	$ 48.3 millones	72.4%

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para 2023 totalizaron $ 22.7 millones, centrados principalmente en los tratamientos de enfermedades cardiovasculares.

• Pruebas de fase I: $ 5.4 millones
• Pruebas de fase II: $ 9.8 millones
• Ensayos de fase III: $ 7.5 millones

Inversiones de cumplimiento regulatorio

Los costos de cumplimiento regulatorio para 2023 fueron de $ 6.2 millones.

Categoría de cumplimiento	Gastos
Costos de envío de la FDA	$ 2.5 millones
Seguro de calidad	$ 2.1 millones
Documentación regulatoria	$ 1.6 millones

Sobrecarga administrativa y operativa

Los gastos administrativos totales para 2023 fueron de $ 15.6 millones.

• Compensación ejecutiva: $ 4.3 millones
• Costos administrativos generales: $ 7.2 millones
• Mantenimiento de la oficina: $ 2.1 millones
• Infraestructura tecnológica: $ 2.0 millones

Gastos de marketing y comunicación científica

Los gastos de marketing para 2023 ascendieron a $ 8.9 millones.

Canal de marketing	Gastos
Conferencias científicas	$ 3.2 millones
Marketing digital	$ 2.7 millones
Imprimir publicaciones	$ 1.5 millones	Programas de enlace médico	$ 1.5 millones

Milestone Pharmaceuticals Inc. (Mist) - Modelo de negocios: flujos de ingresos

Licencias potenciales de productos farmacéuticos

A partir del cuarto trimestre de 2023, Milestone Pharmaceuticals tiene posibles ingresos por licencia específicamente para betaxolol, con un valor de licencia potencial estimado de $ 12.5 millones en acuerdos a corto plazo.

Producto	Ingresos potenciales de licencia	Año proyectado
Betaxolol	$ 12.5 millones	2024-2025

Venta y comercialización futura de drogas

Para la cartera de medicamentos cardiovasculares, el potencial de ventas anual proyectado estimado en $ 45.3 millones para 2025.

• Tratamiento cardiovascular de Vascepa: potencial de ventas estimado de $ 22.7 millones
• Segmento del mercado de betaxolol: ingresos proyectados de $ 15.6 millones
• Tratamientos cardiovasculares adicionales: ingresos potenciales de $ 7 millones

Subvenciones de investigación y fondos colaborativos

Fuentes de financiación de investigación para 2024 proyectadas a $ 3.2 millones de NIH y subvenciones de investigación privada.

Fuente de financiación	Cantidad estimada
NIH Subvenciones	$ 2.1 millones
Subvenciones de investigación privada	$ 1.1 millones

Pagos potenciales de asociación y hito

Pagos de hito anticipados de colaboraciones farmacéuticas estimadas en $ 8.7 millones en 2024.

• Pagos de hitos de desarrollo clínico: $ 5.3 millones
• Pagos de hito de aprobación regulatoria: $ 3.4 millones

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Value Propositions

You're looking at the core benefit Milestone Pharmaceuticals Inc. (MIST) is bringing to the table with CARDAMYST (etripamil) nasal spray, especially as we approach the Prescription Drug User Fee Act (PDUFA) target action date of December 13, 2025. This isn't just another drug; it's a fundamental shift in how symptomatic Paroxysmal Supraventricular Tachycardia (PSVT) is managed.

Self-administered, rapid-response therapy for PSVT episodes.

The primary value is speed and patient control. Clinical data, presented at the American Heart Association Scientific Sessions 2025 on November 10, clearly shows how quickly etripamil works when a patient uses it themselves. Honestly, this speed is what differentiates it from current standards of care that often require an emergency setting.

Efficacy Metric	Data Point	Context
Median Time to Conversion	18.5 minutes (95% CI: 15.7 to 21.0 minutes)	Across patients self-administering etripamil
Conversion Rate by 30 Minutes	59.6% (Range: 53.6% to 64.3%)	Kaplan-Meier estimate from pooled data
Conversion Rate by 60 Minutes	63.2% to 75.1%	Across multiple studies
Safety Data Volume	Over 1,050 patients	Favorable and predominantly mild/transient adverse events
Test-Dose Failure Rate	1.4%	Among over 1,100 patients administered in Sinus Rhythm (SR)

This robust dataset, covering analysis from 622 unique enrolled patients across multiple trial designs, supports the claim of consistent efficacy right after self-administration. Also, the safety profile is strong, with favorable data from over 1,050 etripamil-treated patients.

Potential to reduce costly and inconvenient emergency room visits.

You know the drill: a PSVT episode hits, and the patient often ends up in the Emergency Department (ED), which is both a huge burden on the patient and a significant cost driver for the healthcare system. Milestone Pharmaceuticals is positioning CARDAMYST as the tool to stop this cycle. The potential for rapid, self-administered termination of symptomatic PSVT episodes is precisely what's needed to bypass the ED for many events, a condition that frequently leads to those costly visits.

First new pharmacological option for PSVT in defintely decades.

This is a major differentiator. If approved, CARDAMYST will be the first and only self-administered therapy for the rapid termination of PSVT episodes. This novelty is recognized by the market; results from an independent survey published on May 6, 2025, showed that 40% of respondents, including payers, providers, and academics, selected CARDAMYST as the new drug expected to make the biggest difference in patient health. It's a first-in-class opportunity.

Portable, on-demand treatment empowering patient self-management.

The product is designed to be carried and used immediately, bypassing the need for immediate medical oversight. This aligns perfectly with the company's initial design goal for etripamil nasal spray. The financial preparation for this launch is evident in their Q3 2025 figures, showing a significant ramp-up in commercial expense, which hit $4.6 million for the third quarter of 2025, up from $1.9 million the prior year, reflecting the operational readiness for a commercial rollout.

Here's a quick look at the financial backing for this launch, as of September 30, 2025:

• Cash, cash equivalents, and short-term investments: $82.6 million
• Net proceeds from recent public equity offering: approximately $48.7 million
• Contingent royalty payment upon FDA approval: $75 million
• Commercial expense for nine months ended September 30, 2025: $20.1 million

The ability to deploy this portable treatment is backed by a balance sheet strengthened by the recent equity raise and the expected royalty payment, which management believes will fund a successful commercial launch.

Finance: draft 13-week cash view by Friday.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Customer Relationships

You're preparing for a product launch that hinges on physician adoption and patient self-management, so the relationships you build now are critical. Milestone Pharmaceuticals Inc. (MIST) is clearly structuring its customer relationships around deep clinical engagement and readiness for commercial execution, even while pre-revenue as of late 2025.

High-touch engagement with cardiologists and electrophysiologists

Milestone Pharmaceuticals Inc. has been actively engaging with the cardiology community, using clinical data presentation as a primary touchpoint. This engagement is focused on specialists who manage patients with paroxysmal supraventricular tachycardia (PSVT), which affects over two million Americans, with a target addressable market of approximately 60% of those patients actively managed by cardiologists.

The company presented new analysis from its etripamil clinical trials at the American Heart Association (AHA) Scientific Sessions 2025 on November 10, 2025. This scientific outreach is key to building trust with the prescribers. The data presented covered efficacy and safety from studies involving more than 600 unique enrolled patients. For the self-administered nature of CARDAMYST, the clinical data points are the core of the relationship-building effort:

• Median time to conversion for PSVT to sinus rhythm was 18.5 minutes across studies.
• The Kaplan-Meier estimate for conversion by 30 minutes was 59.6% (range: 53.6% to 64.3%).
• Safety data was favorable across over 1,050 etripamil-treated patients.
• Test-dose failures were low at 1.4% among over 1,100 patients administered etripamil.

This focus on clinical evidence is supported by significant pre-launch spending. Commercial expense for the nine months ending September 30, 2025, reached $20.1 million, up from $6.6 million in the prior year period, directly reflecting the ramp-up in operational expenditures related to launch preparation. That's a big spend before the first dollar of revenue.

Dedicated patient support and education programs post-launch

While Milestone Pharmaceuticals Inc. reported no revenue for the third quarter ended September 30, 2025, as it remains pre-commercial, the nature of its lead product, CARDAMYST (etripamil) nasal spray, mandates a strong patient support infrastructure for self-administration without medical supervision. The company's stated focus is on improving the patient experience and providing patients with an active role in self-managing their care.

The planned customer relationship structure for patients is implied by the commercial readiness activities, though specific post-launch patient support enrollment numbers aren't available yet as of late 2025. Here is what we know about the readiness context:

Metric	Value/Status (As of Q3 2025)
PSVT Target Addressable Market Managed by Cardiologists	Approximately 60% of over 2 million Americans
AFib-RVR Target Market (by 2030)	Up to four to five million patients
Commercial Expense (9 Months Ended 9/30/2025)	$20.1 million
Launch Readiness Posture	Quick-start capability emphasized following the December 13, 2025 PDUFA date

The company is preparing for a potential launch around the December 13, 2025 PDUFA date, which means patient education materials and support systems are a top priority for the commercial team.

Direct communication with investors and financial markets

Milestone Pharmaceuticals Inc. maintains a transparent, though pre-revenue, dialogue with the financial community, which is crucial given its capital-intensive development stage. The company's financial position as of September 30, 2025, reflects recent successful capital raising efforts to support this commercial build-out.

The company completed an underwritten public offering providing immediate net proceeds of approximately $48.7 million in July 2025. This, combined with an amended Royalty Purchase Agreement (RPA), is expected to fund the launch, which includes a $75 million royalty payment upon FDA approval.

Key financial metrics as of the end of Q3 2025 show the capital base supporting these relationships:

• Cash, cash equivalents, and short-term investments: $82.6 million as of September 30, 2025.
• Net Loss for Q3 2025: $11.9 million.
• Management expressed confidence in sustaining operations over the next 12 months.

Direct communication is executed through regular updates and participation in key industry conferences. For instance, the company provided updates at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, and the Jefferies Global Healthcare Conference on June 5, 2025. This consistent presence helps manage market expectations ahead of the critical PDUFA date.

Finance: draft 13-week cash view by Friday.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Channels

You're preparing for a product launch that hinges entirely on effective outreach, so understanding Milestone Pharmaceuticals Inc. (MIST)'s channel strategy as of late 2025 is key. Since the Prescription Drug User Fee Act (PDUFA) target action date for CARDAMYST™ was set for December 13, 2025, the channels discussed here reflect the company's pre-launch build-out and 'quick-start capability' readiness for a mid-2026 revenue ramp, despite earlier mid-2025 launch targets.

Specialty pharmaceutical distributors and pharmacies

For a self-administered therapy like CARDAMYST, access through the right distribution network is non-negotiable. While Milestone Pharmaceuticals Inc. (MIST) hasn't disclosed specific contracts with major specialty pharmaceutical distributors as of late 2025, the entire commercial infrastructure build-out signals that these relationships are being finalized. The company's focus on market access, which is a key component of commercial readiness, means securing favorable formulary placement with payers and establishing efficient logistics with third-party logistics (3PL) providers and specialty pharmacies to ensure the product reaches the patient post-approval. This is the backbone for getting the product from the manufacturer to the patient's hands.

Direct sales force targeting high-volume prescribers

Milestone Pharmaceuticals Inc. (MIST) has been actively scaling its commercial team in anticipation of a positive FDA decision. The initial launch sales team is planned to consist of approximately 60 professionals, with regional sales management expected to be on board in February 2025 to lead this effort. This team is designed to target high-volume prescribers of Paroxysmal Supraventricular Tachycardia (PSVT) treatments. The investment in this channel is evident in the rising commercial expenses reported through the third quarter of 2025.

Here's a look at the financial commitment to activating these commercial channels:

Metric	Q3 2025 Amount	Nine Months Ended Sept 30, 2025 Amount
Commercial Expense	$4.6 million	$20.1 million
Prior Year Q3 Commercial Expense	$1.9 million	$6.6 million (Nine Months Ended Sept 30, 2024)

The jump in commercial expense to $4.6 million in Q3 2025 from $1.9 million in Q3 2024 shows a clear ramp-up in pre-launch activities, including hiring and initial marketing groundwork. Honestly, that nine-month spend of $20.1 million is what you spend when you're serious about a national rollout.

Medical conferences (e.g., AHA, ACC) and peer-reviewed journals

The medical affairs channel is crucial for establishing clinical credibility for CARDAMYST, a first-in-class therapy. Milestone Pharmaceuticals Inc. (MIST) uses major medical meetings to disseminate data and engage key opinion leaders. You can track their channel activity through their conference presence:

• Data from the NODE-303 trial was presented at the American College of Cardiology (ACC25) in March 2025.
• The company participated in the Jefferies Global Healthcare Conference on June 3-5, 2025.
• Executive updates were provided at the H.C. Wainwright 27th Annual Global Investment Conference on September 8-10, 2025.
• New analyses from etripamil clinical trials were presented at the American Heart Association (AHA) Scientific Sessions 2025 on November 10.

Also, etripamil gained recognition in the latest AHA Advanced Cardiovascular Life Support (ACLS) Guidelines, which is a massive channel endorsement.

Digital marketing and patient advocacy groups

While specific digital marketing spend figures aren't itemized separately from the general commercial expense, the strategy is clearly in place. The company highlighted CARDAMYST in an independent Survey of Managed Care professionals in Q1 2025, which is a form of targeted professional outreach that bridges marketing and market access. Furthermore, the product is designed to empower patients to self-manage episodes, which inherently requires a strong patient-facing digital and advocacy channel strategy to drive adoption and adherence. The company's focus on patient-centric care suggests this channel is a high priority for post-approval execution.

Finance: finalize the Q4 2025 commercial expense projection by next Tuesday.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Customer Segments

You're preparing for the CARDAMYST (etripamil) nasal spray launch, pending the December 13, 2025, PDUFA date. Understanding who needs this product is step one.

Patients with symptomatic Paroxysmal Supraventricular Tachycardia (PSVT)

This is the immediate, primary target. The prevalence data suggests a significant, though relatively rare, patient pool in the US. We project annual prevalence estimates based on claims data for patients under age 65 ranged from 1,107,101 to 1,396,182 unique PSVT patients over a single study year. You should know that the national prevalence of symptomatic PSVT has been estimated as high as 168 per 100,000 adults. To be fair, in a prior analysis, the prevalence of symptomatic PSVT was 140 per 100,000 (95% confidence interval, 100 to 179). Also, 24% of incident cases documented PSVT at the first symptomatic episode, indicating a segment that may not have prior treatment experience.

Here's the quick math on the US symptomatic PSVT population estimates:

Metric	Value	Source Context
Estimated National Prevalence (High)	168 per 100,000 adults	General US Population Estimate
Estimated National Prevalence (Low)	140 per 100,000 adults	Kaiser Permanente Study Estimate
Projected Annual Unique Patients (<65 Yrs)	Max 1,396,182	Claims Data Projection
PSVT Prevalence (General Population)	Approx. 0.2%	General Prevalence Figure

If onboarding takes 14+ days, churn risk rises.

Cardiologists and Electrophysiologists (primary prescribers)

These are the gatekeepers who will write the first prescriptions for CARDAMYST, especially given that contemporary guidelines recommend electrophysiology study and ablation as first-line treatment, leaving a gap for acute, self-administered management. We have data from the clinical program that supports their interest.

• Results from over 600 unique enrolled patients showed aligned efficacy and safety of etripamil across multiple study phases presented at AHA Scientific Sessions 2025 on November 10.
• A 2024 Citi survey polled 72 specialized physicians on new technologies, split evenly between 36 electrophysiologists and 36 cardiovascular surgeons.
• The company's commercial expense ramped to $20.1 million for the nine months ending September 30, 2025, reflecting investment in the prescriber base preparation.

Managed Care Organizations (MCOs) and other third-party payers

Payer acceptance dictates patient access and, ultimately, revenue realization. The company is preparing for launch with a strengthened balance sheet, which includes $82.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025. Furthermore, a $75 million royalty payment is contingent upon FDA approval. This financial footing supports the planned quick-start launch capability.

Payer sentiment is a key leading indicator for formulary success:

Survey/Metric	Finding	Date Context
Top Drug for Patient Health Impact (Payer/Provider Survey)	Selected by 40% of respondents	May 6, 2025
Q3 2025 Commercial Expense	$4.6 million	Pre-launch/Payer Engagement Costs
Net Proceeds from Equity Offering (July 2025)	Approx. $48.7 million	Funding Launch Readiness

Patients with Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR) (future)

This represents a significant future expansion segment, though the NDA for this indication was submitted in October 2023, and enrollment for the Phase 3 trial was paused to prioritize the PSVT CRL resolution. The broader Atrial Fibrillation market provides context for this potential market size. The Global Atrial Fibrillation Market is estimated to be valued at USD 26.43 Bn in 2025. In the US specifically, approximately 5 million Americans were living with AFib as of March 2025, with projections surpassing 12 million by 2030. The pharmacological treatments segment held the largest revenue share of 53.6% in 2025 globally.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Cost Structure

You're looking at the cost side of Milestone Pharmaceuticals Inc. as they stand right before the December 13, 2025, PDUFA date for CARDAMYST. The costs are heavily weighted toward getting the drug to market, which is typical for a pre-commercial biotech.

The primary cost drivers reflect the ramp-up for the potential launch of CARDAMYST (etripamil) nasal spray for symptomatic PSVT (Paroxysmal Supraventricular Tachycardia). You can see the financial commitment in the operating expenses reported through the third quarter of 2025.

Expense Category	Q3 2025 Amount	Nine Months Ended September 30, 2025 Amount
Commercial Expense	$4.6 million	$20.1 million
Research and Development (R&D) Expense	$3.9 million	$12.6 million
General and Administrative (G&A) Expense	$3.3 million	$12.2 million

Commercial launch expenses totaled $20.1 million through the first nine months of 2025, a significant jump from $6.6 million in the prior year period. This spending covers the necessary operational expenditures to launch quickly upon potential FDA approval.

Research and Development (R&D) costs for pipeline expansion, specifically for etripamil in the AFib-RVR indication, show a continued investment, though enrollment initiation for the Phase 3 ReVeRA-301 study is paused to prioritize the PSVT launch readiness.

• R&D expense for the nine months ended September 30, 2025, was $12.6 million.
• This R&D increase was primarily due to higher consulting and outside service costs.
• The Phase 3 protocol for AFib-RVR was finalized, but enrollment start is currently paused.

Manufacturing, quality control, and supply chain logistics costs are embedded within the operating expenses, particularly the rising Commercial Expense, which includes operational expenses for launch preparation. Milestone Pharmaceuticals Inc. is currently pre-revenue, with no sales reported for Q3 2025.

General and Administrative (G&A) overhead and personnel costs saw a slight moderation year-over-year for the nine-month period, though they still represent a fixed cost base.

• G&A expense for the nine months ended September 30, 2025, was $12.2 million.
• The Q3 2025 G&A expense was $3.3 million, down from $3.7 million in Q3 2024, primarily due to a decrease in professional fees and personnel costs between those quarters.

The company's cash position is a key factor in funding these costs. As of September 30, 2025, Milestone Pharmaceuticals Inc. held $82.6 million in cash, cash equivalents, and short-term investments. This balance was bolstered by net proceeds of approximately $48.7 million from an equity offering and an amended Royalty Purchase Agreement in July 2025. Furthermore, a potential $75 million royalty payment upon FDA approval is expected to support the commercial launch.

The overall cost of operations resulted in a net loss of $45.6 million for the first nine months of 2025.

Finance: draft 13-week cash view by Friday.

Milestone Pharmaceuticals Inc. (MIST) - Canvas Business Model: Revenue Streams

You're looking at Milestone Pharmaceuticals Inc.'s revenue picture as of late 2025, which is entirely focused on the near-term binary event of the FDA decision for CARDAMYST™ (etripamil) nasal spray. Honestly, the current revenue is zero, which is expected for a pre-commercial company, but the potential future inflows are what matter right now.

Milestone Payment Upon Potential FDA Approval

The most immediate, concrete financial event tied to revenue streams is the milestone payment contingent on FDA approval for the lead indication, Paroxysmal Supraventricular Tachycardia (PSVT). Milestone Pharmaceuticals has an agreement in place to receive this cash infusion, which is a key component of their launch funding.

• Contingent payment amount: $75 million.
• Trigger: Potential FDA approval of CARDAMYST for PSVT.
• PDUFA target action date: December 13, 2025.
• The associated Royalty Purchase Agreement (RPA) with RTW Investments was extended to December 31, 2025, to cover this eventuality.

This $75 million is expected to be a non-dilutive source of capital, bolstering the balance sheet which stood at $82.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025. That cash position was strengthened by a recent equity financing of approximately $48.7 million in net proceeds.

Product Sales of CARDAMYST™ (etripamil) Post-Commercial Launch

As of the third quarter of 2025, Milestone Pharmaceuticals reported no revenue, which aligns with the expectation that 2025 sales would be $0.0M since the company is pre-commercial and awaiting the December regulatory decision. The commercial team is fully prepared for a 'quick-start capability' upon approval, meaning sales would realistically begin generating revenue in early 2026, not 2025.

The market opportunity for the PSVT indication alone is estimated to be a $1.2 billion market by 2028, assuming 15% market penetration.

Potential Future Royalty Payments from the RTW Investments Agreement

The $75 million payment is tied to a Royalty Purchase Agreement (RPA) with RTW Investments, which converts into tiered royalty payments on U.S. net sales of etripamil post-approval. This structure creates a long-term, albeit variable, revenue stream dependent on commercial success.

Here's how those tiered royalty rates are structured based on annual net sales thresholds:

Annual Net Sales Threshold	Royalty Rate Paid to RTW Investments
Up to $500 million	7% (Initial Tier Royalty)
Greater than $500 million and less than or equal to $800 million	4%
Greater than $800 million	1%

To be fair, if certain revenue thresholds are missed, the Initial Tier Royalty can increase to 9.5% starting January 1 of the following calendar year until a subsequent sales threshold is met.

Future Product Sales from the AFib-RVR Indication (Pipeline)

While PSVT is the immediate focus, the second indication for Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR) represents a significant upside to future product sales, though it is further out on the timeline. Milestone Pharmaceuticals has finalized the Phase 3 protocol (ReVeRA-301), but enrollment initiation is currently paused to prioritize the PSVT launch readiness.

• The Phase 3 protocol for AFib-RVR is finalized.
• Enrollment initiation is paused to focus on the PSVT launch.
• Analyst projections suggest potential revenue over $1 billion if both PSVT and AFib-RVR indications are approved.

So, you're looking at a revenue model that transitions from a single, large, contingent payment in late 2025 to a commercial product stream in 2026, with a second, major revenue driver still in the pipeline. Finance: draft 13-week cash view by Friday.